Treatment of Apathy in Alzheimer's Disease With Modafinil
This study has been completed.
Sponsor:
Brown University
Collaborators:
Cephalon
Information provided by:
Brown University
ClinicalTrials.gov Identifier:
NCT01172145
First received: July 28, 2010
Last updated: February 9, 2011
Last verified: September 2010
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Purpose
This study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's disease (AD).
| Condition | Intervention | Phase |
|---|---|---|
|
Apathy Alzheimer's Disease |
Drug: Modafinil Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment of Apathy in Alzheimer's Disease With Modafinil |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Brown University:
Primary Outcome Measures:
- Apathy [ Time Frame: at baseline ] [ Designated as safety issue: No ]The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.
- Apathy [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.
Secondary Outcome Measures:
- Lawton Brody Activities of Daily Living Questionnaire [ Time Frame: at baseline ] [ Designated as safety issue: No ]Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.
- The Direct Assessment of Functional Status Scale [ Time Frame: at baseline ] [ Designated as safety issue: No ]A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.
- Zarit Burden Inventory [ Time Frame: at baseline ] [ Designated as safety issue: No ]Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.
- Lawton Brody Activities of Daily Living Questionnaire [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.
- The Direct Assessment of Functional Status Scale [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.
- Zarit Burden Inventory [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.
| Enrollment: | 22 |
| Study Start Date: | July 2005 |
| Study Completion Date: | September 2007 |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Cholinesterase inhibitor only |
Drug: Placebo
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
|
| Experimental: Cholinesterase Plus Modafinil |
Drug: Modafinil
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
Other Name: Provigil
|
Eligibility| Ages Eligible for Study: | 65 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- diagnosis of mild to moderate stage Probable Alzheimer's disease
- on a stable dose of a cholinesterase inhibitor medication for at least 30 days
- clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale
Exclusion Criteria:
- diagnosis of Major Depression
- focal brain lesion on neuroimaging
- history of significant substance abuse
- history of significant head trauma with loss if consciousness >10 minutes
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172145
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172145
Locations
| United States, Rhode Island | |
| Butler Hospital | |
| Providence, Rhode Island, United States, 02906 | |
Sponsors and Collaborators
Brown University
Cephalon
Investigators
| Principal Investigator: | Laura L Frakey, Ph.D. | Memorial Hospital of Rhode Island |
More Information
No publications provided by Brown University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Laura L. Frakey, Brown University |
| ClinicalTrials.gov Identifier: | NCT01172145 History of Changes |
| Other Study ID Numbers: | 1F32MH075583-01, 1F32MH075583-01 |
| Study First Received: | July 28, 2010 |
| Results First Received: | August 4, 2010 |
| Last Updated: | February 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brown University:
|
apathy Alzheimer's disease activities of daily living performance caregiver burden |
Additional relevant MeSH terms:
|
Alzheimer Disease Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Dementia Mental Disorders Nervous System Diseases Neurodegenerative Diseases Tauopathies |
Armodafinil Modafinil Central Nervous System Agents Central Nervous System Stimulants Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Wakefulness-Promoting Agents |
ClinicalTrials.gov processed this record on March 03, 2015